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Home Merck and Eisai’s Immuno-Oncology Combo Keytruda + Lenvima Nears EU Approval for Advanced RCC and Endometrial Cancer

Merck and Eisai’s Immuno-Oncology Combo Keytruda + Lenvima Nears EU Approval for Advanced RCC and Endometrial Cancer

Oct 18, 2021 00:48 CST Updated 00:48
MSD

Pharmaceutical R&D and Manufacturer

Eisai

Pharmaceutical Product R&D and Manufacturer

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


Kidney cancer (Image source: vecteezy.com)

October 16, 2021 /BioonBIOON/ -- MSD (Merck & Co.) and partner Eisai recently jointly announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending approvalCombination regimen of anti-PD-1 therapy Keytruda (generic name: pembrolizumab) and oral multi-receptor tyrosine kinase inhibitor Lenvima (EU brand name: Kisplyx; generic name: lenvatinib), indicated for two distinct patient populations: (1) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC); (2) for the treatment of adult patients with advanced or recurrent endometrial cancer (EC) whose disease has progressed following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation therapy.

The CHMP opinion will now be submitted to the European Commission (EC) for review, which is expected to issue its final decision in the fourth quarter of this year.If approved, this will be the first time in the European Union that an anti-PD-1 therapy is used in combination with a tyrosine kinase inhibitor for the treatment of two different types of cancer.

Keytruda + Lenvima is an "immunotherapy + targeted therapy" combination therapy.，was approved in the United States in August and July 2021 for the treatment of RCC and EC, respectively. Specifically: (1) for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). (2) for the treatment of patients with advanced endometrial cancer (EC) who have disease progression following prior systemic therapy in any setting, who are not candidates for curative surgery or radiation therapy, and whose tumors are confirmed by testing to be not microsatellite instability-high (MSI-H) or not deficient mismatch repair (dMMR); herein, "not MSI-H or not dMMR" is also referred to as "non-microsatellite instability-high (non-MSI-H) or proficient mismatch repair (pMMR)".

Endometrial cancer (Image source: womenworking.com)

CHMP positive opinion, based on two pivotal Phase 3 trialsClinical TrialData: The CLEAR (Study 307/KEYNOTE-581) trial evaluated combination therapy in adult patients with advanced RCC, and the KEYNOTE-775/Study 309 trial evaluated combination therapy in patients with certain advanced EC.

The Phase 3 CLEAR trial results showed:Compared with sunitinib, Keytruda plus Lenvima demonstrated statistically significant improvements across multiple efficacy endpoints (overall survival [OS], progression-free survival [PFS], and objective response rate [ORR]):(1) 34% reduction in the risk of death (HR=0.66 [95% CI: 0.49–0.88]; p=0.0049); (2) 61% reduction in the risk of disease progression or death (HR=0.39 [95% CI: 0.32–0.49]; p<0.0001), with significantly prolonged PFS (median: 23.9 months vs 9.2 months); (3) significantly improved ORR (71% vs 36%; p<0.001).

KEYNOTE-775/Study 309 trial results show:Compared with chemotherapy (investigator’s choice: doxorubicin or paclitaxel), the Keytruda plus Lenvima regimen demonstrated statistically significant and clinically meaningful improvements in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as well as the secondary endpoint of overall response rate (ORR).: (1) a 38% reduction in the risk of death (HR=0.62 [95% CI: 0.51-0.75]; p < 0.0001) and significantly prolonged OS (median: 18.3 months vs 11.4 months); (2) a 44% reduction in the risk of disease progression or death (HR=0.56 [95% CI: 0.47-0.66]; p < 0.0001) and significantly prolonged PFS (median: 7.2 months vs 3.8 months).

The Keytruda + Lenvima combination therapy is part of the strategic oncology collaboration between MSD and Eisai. In March 2018, the two companies signed a collaboration agreement valued at up to $5.8 billion to develop Lenvima as a monotherapy and in combination with Keytruda for multiple types of...Tumortreatment.

Keytruda is an anti-PD-1 cancer immunotherapy that enhances the ability of the human immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating immune responses that may affect`Tumor`T lymphocytes of cells and healthy cells.

Lenvima is an oral multi-receptor tyrosine kinase (RTK) inhibitor featuring a novel binding mode that, in addition to inhibiting those involved in tumor angiogenesis, tumor progression, andTumorIn addition to inhibiting other receptor tyrosine kinases (RTKs) involved in pro-angiogenic and oncogenic signaling pathways (including platelet-derived growth factor (PDGF) receptor PDGFRα, KIT, and RET), it also selectively inhibits the kinase activity of vascular endothelial growth factor (VEGF) receptors (VEGFR1, VEGFR2, VEGFR3) and fibroblast growth factor (FGF) receptors (FGFR1, FGFR2, FGFR3, FGFR4).

Currently, MSD and Eisai are advancing the LEAP (Lenvatinib and Pembrolizumab) clinical development program across 14 different tumor types (endometrial cancer, hepatocellular carcinoma,Melanoma, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, urothelial carcinoma, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer, pancreatic cancer, and triple-negativeBreast cancer) of more than 20 itemsClinical Trial...continue to study the Keytruda + Lenvima combination. Data from this program indicate that the Keytruda + Lenvima combination has already demonstrated efficacy across various types ofTumordemonstrated robust efficacy! (Bioon.com)